A School-based Prevention Intervention to Promote Wellbeing in Preadolescents (DDS)
|ClinicalTrials.gov Identifier: NCT01720199|
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Risk Factors for Noncommunicable Diseases||Other: Diario della Salute (DDS)||Not Applicable|
Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:
- social-cognitive theory (Bandura, 1977; 1986)
- theory of multiple intelligences (Gardner, 1987)
- emotional intelligence theory (Goleman, 1997)
- theory of planned behavior (Ajzen, 1991)
- transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).
DDS is composed by:
tools for children and their parents on health and social and emotional well-being issues:
- a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
- a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
- five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.
Assignment of schools to study arms (DDS intervention vs. no intervention) will be cluster-randomized. Schools will be matched by number of students and average socioeconomic status. In some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools.
Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. Pre and post surveys will be linked through an anonymous code (Galanti, 2006).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2630 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Intervention group
Preadolescents allocated to the Diario della Salute (DDS) intervention.
Other: Diario della Salute (DDS)
DDS is composed by
|No Intervention: Control group|
- Self-reported Social And Emotional Well-Being [ Time Frame: Past 30 Days ]Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).
- Self-reported Cigarette Use [ Time Frame: Past 30 Days ]Frequency of cigarette smoking
- Self-reported Drunkenness Episode(s) [ Time Frame: Past 30 Days ]Frequency of drunkenness episodes
- Self-reported Dietary Habits [ Time Frame: Past 30 Days ]Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
- Self-reported Frequency of Physical Exercise [ Time Frame: Past 30 Days ]Frequency of moderate and heavy physical exercise
- Self-reported Physical and Verbal Aggression [ Time Frame: Past 30 Days ]Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720199
|Azienda Sanitaria Locale CN2 Alba-Bra|
|Alba, Cuneo, Italy, 12051|
|Principal Investigator:||Fabrizio Faggiano, MD||University of Eastern Piedmont|
|Study Chair:||Antonella Ermacora, MSc||Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.|
|Study Director:||Elias Allara, MD||University of Eastern Piedmont|